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Medical Device Embedded System Engineer Jobs in Wisconsin

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Medical Device Embedded System Engineer information

What does a medical device embedded system engineer do?

A Medical Device Embedded System Engineer designs, develops, and maintains the embedded software and hardware used in medical devices such as pacemakers, infusion pumps, and diagnostic equipment. They ensure that the systems meet strict safety, reliability, and regulatory standards required in the healthcare industry. Their work involves programming microcontrollers, integrating sensors and communication modules, and collaborating with cross-functional teams to ensure the final product is safe, effective, and compliant with medical regulations.

How does a medical device embedded system engineer typically collaborate with cross-functional teams during product development?

As a Medical Device Embedded System Engineer, you’ll work closely with teams such as hardware engineers, software developers, quality assurance, regulatory affairs, and clinical experts. Collaboration is essential to ensure the embedded system meets safety, performance, and regulatory requirements. This often involves participating in design reviews, troubleshooting integration issues, and providing technical documentation. Effective communication and teamwork are key, as you’ll be translating clinical needs into technical solutions and ensuring compliance with medical standards.

What are the key skills and qualifications needed to thrive as a medical device embedded system engineer, and why are they important?

A Medical Device Embedded System Engineer typically needs a strong background in electrical or computer engineering, experience with embedded C/C++ programming, and a solid understanding of medical device regulations. Familiarity with microcontrollers, real-time operating systems (RTOS), and compliance standards like IEC 62304 is highly valuable, and certifications in embedded systems or medical device software can be advantageous. Strong problem-solving skills, attention to detail, and effective teamwork are essential soft skills for excelling in this position. These competencies ensure the development of safe, reliable, and regulatory-compliant medical devices that improve patient outcomes.

What is the difference between Medical Device Embedded System Engineer vs Medical Software Engineer?

AspectMedical Device Embedded System EngineerMedical Software Engineer
CredentialsBachelor's or higher in Electrical, Computer Engineering, or related; knowledge of embedded systemsBachelor's or higher in Computer Science, Software Engineering, or related; programming skills
Work EnvironmentDesigning and testing embedded hardware/software for medical devicesDeveloping medical software applications, often on PCs or servers
Industry UsageUsed in medical devices like pacemakers, imaging equipment, and monitorsUsed in healthcare software, EHR systems, and medical data analysis

The Medical Device Embedded System Engineer focuses on developing embedded hardware and firmware for medical devices, ensuring safety and compliance. In contrast, the Medical Software Engineer primarily develops software applications used in healthcare settings. Both roles require technical expertise but differ in their focus on hardware versus software development within the medical industry.

What are popular job titles related to Medical Device Embedded System Engineer jobs in Wisconsin?

For Medical Device Embedded System Engineer jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Medical Device Embedded System Engineer jobs in Wisconsin look for?

The top searched job categories for Medical Device Embedded System Engineer jobs in Wisconsin are:

What cities in Wisconsin are hiring for Medical Device Embedded System Engineer jobs?

Cities in Wisconsin with the most Medical Device Embedded System Engineer job openings:

Medical Device Embedded System Engineer jobs near you

Medical Device Quality Inspector

Madison, WI • On-site

Kellton Tech
See more jobs at Kellton Techexternal

$30/hr

Contractor

Re-posted 17 days ago

Job description

Job Title: Medical Device Quality Inspector
Location: Madison, WI (Onsite)
Pay Rate: $30/hr (W2)
 

Job Summary

The Medical Device Quality Inspector is responsible for ensuring that materials, processes, and conditions related to the daily manufacturing, processing, and packaging of medical devices meet cGMP standards and comply with internal quality procedures and regulatory standards. This position plays a critical role in ensuring product quality and integrity in a regulated environment.

Essential Functions

  • Perform one of the following Quality department functions:
    • Inspect raw materials to ensure they meet production requirements.
    • Conduct in-process inspections of products and manufacturing processes.
    • Review final documentation and inspect packaging for medical devices, subassemblies, and kits.
  • Assist in documentation control activities within the manufacturing facility.
  • Complete activity documentation and attach appropriate quality status labeling.
  • Ensure proper storage and secure handling of products and labels.
  • Support the Quality team by occasionally conducting nonconformance investigations and assisting with preventive actions.
  • Perform quality reviews for quarantine releases on specific non-reportable, non-complaint materials.

Minimum Requirements

Education & Experience:

  • High School diploma or equivalent required.
  • Minimum 1 year of experience in a regulated work environment preferred.
  • Familiarity with FDA Quality System Regulations and ISO 13485 standards for medical device manufacturing.

Skills & Competencies:

  • Self-motivated and able to work independently.
  • Strong attention to detail.
  • Proficient in using computer-based systems daily.
  • Strong teamwork and collaboration skills.
  • Effective verbal and written communication abilities.

Organizational Relationship / Scope

  • Reports to the Quality Control Manager.
  • Interfaces primarily with manufacturing, engineering, and quality departments to assess nonconforming products and support supplier quality issues.

Working Conditions

  • Work is performed in a controlled environment within a medical device manufacturing facility.
  • Adherence to safety and hygiene protocols is required.